Incidence of Myopia in a Prospective Cohort of Emmetropic Children and Associated Ocular and Environmental Factors

ConditionMyopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-8
SponsorFondation Ophtalmologique Adolphe de Rothschild

About this trial

Myopia and high myopia are among the leading causes of visual impairment and blindness worldwide. The total number of people with myopia worldwide was estimated at 2.6 billion in 2020 and could reach 4.8 billion by 2050 unless preventive interventions are implemented.

Most epidemiological studies have focused on risk factors for myopia progression, with far fewer addressing the factors that cause a child to shift from emmetropia to myopia. The risk factors for the onset of myopia may be the same as those for myopia progression. However, for an equivalent level of risk exposure, it remains unclear why some children develop myopia while others do not.

Identifying the population most at risk of developing myopia would make it possible to propose preventive treatments aimed at delaying or preventing its onset. This would allow evaluation of the effectiveness of current myopia control treatments (peripheral defocus lenses, atropine, contact lenses) in preventing the onset of myopia, as well as future targeted treatments, including the potential benefit of early optical correction-a strategy once used but later abandoned due to a lack of robust scientific evidence.

The establishment of longitudinal follow-up of young emmetropic children at the French Institute of Myopia will enable the acquisition of high-quality imaging, allowing investigation of the association between advanced imaging parameters and external environmental factors with the onset of myopia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 4 years and < 9 years

Spherical equivalent measured by autorefractometer ≥ 0.00 and ≤ +2.00 diopters in each eye (cycloplegic autorefraction)

Disqualifiers

Presence of trauma in at least one eye

Presence of inflammatory ocular pathology in at least one eye

History of intraocular pressure-lowering ophthalmic treatment, intravitreal injections, laser treatment, or myopia control therapy (e.g., atropine, orthokeratology, myopia control lenses)

History of ophthalmic surgery other than for the management of strabismus (e.g., cataract surgery, filtering surgery, intravitreal surgery) in at least one eye

Trial population

Children aged 4 to 8 years at inclusion, emmetropic (cycloplegic refractive error between 0 and +2 diopters - inclusive - in spherical equivalent in each eye).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • annual follow-up

    Other intervention

    annual follow-up including ophtalmologic examination and biometry and behavioural questionnaires

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Children aged 4 to 8 years at inclusion, emmetropic (cycloplegic SE 0 to +2D) in each eye d1 intervention

Trial outcomes

Primary outcomes

1

To describe the incidence of myopia over the 2 years following inclusion in emmetropic children.

Onset of myopia within the 2 years following inclusion, defined as a spherical equivalent (SE) ≤ -0.50 D in at least one eye. Measurement of the spherical equivalent will be performed under cycloplegia using an autorefractor.

Time frame
Annual follow up : Year 1 and year 2

Secondary outcomes

1

To describe the incidence of myopia over the 5 years following inclusion in emmetropic children.

Onset of myopia within the 5 years following inclusion, defined as a spherical equivalent (SE) ≤ -0.50 D in at least one eye. Measurement of the spherical equivalent will be performed under cycloplegia using an autorefractor.

Time frame
annual follow-up until Year 5

Other outcomes

Sponsors and contacts

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